Intestinal Research

Original Articles

IBD

Efficacy and safety of mirikizumab as induction and maintenance therapy for Japanese patients with moderately to severely active ulcerative colitis: a subgroup analysis of the global phase 3 LUCENT-1 and LUCENT-2 studies: Taku Kobayashi, Katsuyoshi Matsuoka, Mamoru Watanabe, Tadakazu Hisamatsu, Fumihito Hirai, Joe Milata, Xingyuan Li, Nathan Morris, Vipin Arora, Tomoko Ishizuka, Koji Matsuo, Yoichi Satoi, Catherine Milch, Toshifumi Hibi; Intest Res 2024;22(2):172-185. Published online April 25, 2024; DOI: https://doi.org/10.5217/ir.2023.00043

Abstract PDF Supplementary Material PubReader ePub: Background/Aims
Mirikizumab is a p19-directed anti-interleukin-23 antibody with potential efficacy against ulcerative colitis (UC). We evaluated the efficacy and safety of mirikizumab in a Japanese subpopulation with moderately to severely active UC from the LUCENT-1 and LUCENT-2 studies.
Methods
LUCENT-1 and LUCENT-2 were phase 3, randomized, double-blind, placebo-controlled trials of mirikizumab therapy in adults with moderately to severely active UC. LUCENT-1 was a 12-week induction trial where patients were randomized 3:1 to receive intravenous mirikizumab 300 mg or placebo every 4 weeks (Q4W). Patients achieving a clinical response with mirikizumab following the induction study were re-randomized 2:1 to double-blind treatment with either mirikizumab 200 mg or placebo subcutaneously Q4W during the 40-week maintenance study. The primary outcomes were clinical remission at week 12 of LUCENT-1 and week 40 of LUCENT-2.
Results
A total of 137 patients enrolled in Japan were randomized to mirikizumab (n = 102) or placebo (n = 35). Compared with placebo, patients who received mirikizumab showed numerically higher clinical remission at week 12 of induction (32.4% [n = 33] vs. 2.9% [n = 1]) and at week 40 of maintenance (48.9% [n = 23] vs. 28.0% [n = 7]). A greater number of patients achieved key secondary endpoints in the mirikizumab group compared with placebo. The frequency of treatment-emergent adverse events was similar across mirikizumab and placebo groups. Efficacy and safety results observed in the Japanese subpopulation were generally consistent with those in the overall population.
Conclusions
Mirikizumab induction and maintenance treatments were effective in Japanese patients with moderately to severely active UC. No new safety concerns were identified.

3,478 View
212 Download
1 Web of Science

IBD

Clinical features of very early-onset inflammatory bowel disease in Japan: a retrospective single-center study: Masaaki Usami, Ichiro Takeuchi, Reiko Kyodo, Yuri Hirano, Kosuke Kashiwagi, Hiroki Fujikawa, Hirotaka Shimizu, Toshinao Kawai, Katsuhiro Arai; Intest Res 2022;20(4):475-481. Published online June 13, 2022; DOI: https://doi.org/10.5217/ir.2021.00142

Abstract PDF PubReader ePub

Background/Aims
Very early-onset inflammatory bowel disease (VEO-IBD), defined as IBD diagnosed in patients younger than 6 years, is a challenge for pediatric gastroenterologists. Although there have been reports regarding VEO-IBD in Western countries, those in Asia are still lacking. This study aimed to investigate the clinical features of Japanese VEO-IBD patients.
Methods
Patients with VEO-IBD diagnosed between 2006 and 2019 were evaluated retrospectively. The disease phenotypes were classified into ulcerative colitis type (UC-type) and Crohn’s disease type (CD-type), and the clinical features and courses were compared between the phenotypes.
Results
Overall, 54 VEO-IBD patients (19 patients with UC-type and 35 patients with CD-type) were evaluated. The median age at onset was 18 months. One patient had severe combined immunodeficiency (SCID), and 9 patients had monogenic IBD. Monogenic IBD was more prevalent in the CD-type patients with perianal disease (CD-type (PD)). The age at onset was significantly lower in the CD-type group (P<0.05). The most common initial symptom was bloody stools (70%), followed by diarrhea (63%), weight loss (24%), fever (20%), and perianal disease (20%). Excluding patients with SCID and monogenic IBD, 23 out of 44 patients (52%) required biologics. The biologics were switched in 11 out of 44 patients (25%), and the majority of these patients (82%) were in the CD-type group. Overall, 9 patients (20%) required intestinal resection or ostomy placement.
Conclusions
CD-type tends to occur at an earlier age, and monogenic IBD occurs significantly more frequently in CD-type (PD). Disease severity and treatment should be individualized, owing to the disease heterogeneity.

Citations

Citations to this article as recorded by

Impact of age at diagnosis on long‐term prognosis in patients with intestinal Behçet's disease
Ji Young Chang, Soo Jung Park, Jae Jun Park, Tae Il Kim, Jae Hee Cheon, Jihye Park
Journal of Gastroenterology and Hepatology.2024; 39(3): 519. CrossRef
Neither hepatic steatosis nor fibrosis is associated with clinical outcomes in patients with intestinal Behçet’s disease
Hye Kyung Hyun, Jihye Park, Soo Jung Park, Jae Jun Park, Tae Il Kim, Jae Seung Lee, Hye Won Lee, Beom Kyung Kim, Jun Yong Park, Do Young Kim, Sang Hoon Ahn, Seung Up Kim, Jae Hee Cheon
European Journal of Gastroenterology & Hepatology.2024; 36(4): 445. CrossRef
Surgical outcomes of very-early-onset ulcerative colitis: retrospective comparative study with older pediatric patients
Takashi Fumita, Keita Terui, Ryohei Shibata, Ayako Takenouchi, Shugo Komatsu, Satoru Oita, Hiroko Yoshizawa, Yuichi Hirano, Yusaku Yoshino, Takeshi Saito, Tomoro Hishiki
Pediatric Surgery International.2024;[Epub] CrossRef
Fecal Calprotectin at Postinduction Is Capable of Predicting Persistent Remission and Endoscopic Healing after 1 Year of Treatment with Infliximab in Pediatric Patients with Crohn’s Disease
Yoo Min Lee, Eun Sil Kim, Sujin Choi, Hyo-Jeong Jang, Yu Bin Kim, So Yoon Choi, Byung-Ho Choe, Ben Kang
Gut and Liver.2024; 18(3): 498. CrossRef
Genomic testing identifies monogenic causes in patients with very early-onset inflammatory bowel disease: a multicenter survey in an Iranian cohort
Golnaz Eslamian, Mahnaz Jamee, Tooba Momen, Pejman Rohani, Sarehossadat Ebrahimi, Mehrnaz Mesdaghi, Soodeh Ghadimi, Mahboubeh Mansouri, Seyed Alireza Mahdaviani, Mahnaz Sadeghi-shabestari, Morteza Fallahpour, Bibi Shahin Shamsian, Narges Eslami, Samin Sha
Clinical and Experimental Immunology.2024; 217(1): 1. CrossRef

3,380 View
377 Download
5 Web of Science
5 Crossref

IBD

Efficacy and safety of filgotinib as induction and maintenance therapy for Japanese patients with moderately to severely active ulcerative colitis: a post-hoc analysis of the phase 2b/3 SELECTION trial: Toshifumi Hibi, Satoshi Motoya, Tadakazu Hisamatsu, Fumihito Hirai, Kenji Watanabe, Katsuyoshi Matsuoka, Masayuki Saruta, Taku Kobayashi, Brian G Feagan, Chantal Tasset, Robin Besuyen, Chohee Yun, Gerald Crans, Jie Zhang, Akira Kondo, Mamoru Watanabe; Intest Res 2023;21(1):110-125. Published online March 11, 2022; DOI: https://doi.org/10.5217/ir.2021.00143

Abstract PDF Supplementary Material PubReader ePub

Background/Aims
The safety and efficacy of filgotinib, a once-daily oral Janus kinase 1 preferential inhibitor, were evaluated in Japanese patients with ulcerative colitis (UC) in the phase 2b/3 SELECTION trial.
Methods
SELECTION (NCT02914522) was a randomized, placebo-controlled trial comprising 2 induction studies and a maintenance study. Adults with moderately to severely active UC were randomized in induction study A (biologic-naïve) or B (biologic-experienced) to receive filgotinib 200 mg, 100 mg, or placebo once daily for 11 weeks. Patients in clinical remission or Mayo Clinic score response at week 10 entered the 47-week maintenance study. Efficacy and safety outcomes were assessed in Japanese patients enrolled in Japan.
Results
Overall, 37 and 72 Japanese patients were enrolled in Japan in induction studies A and B, respectively, and 54 entered the maintenance study. Numerically higher proportions of filgotinib 200 mg-treated than placebo-treated patients achieved clinical remission in induction study A (4/15 [26.7%] vs. 0/6 [0%]) and the maintenance study (5/20 [25.0%] vs. 0/9 [0%]), but not induction study B (1/29 [3.4%] vs. 1/14 [7.1%]). Both doses were well tolerated, and no new safety signals were noted. Herpes zoster was reported in 1 filgotinib 200 mg-treated patient in each of induction study A (2.3%, 1/44) and the maintenance study (5.0%, 1/20).
Conclusions
These data, alongside those of the overall SELECTION population, suggest the potential of filgotinib 200 mg as a viable treatment option for Japanese patients with UC. Owing to small patient numbers, data should be interpreted cautiously.

Citations

Citations to this article as recorded by

Efficacy and safety of filgotinib for ulcerative colitis: A real‐world multicenter retrospective study in Japan
Shintaro Akiyama, Kaoru Yokoyama, Soichi Yagi, Shinichiro Shinzaki, Kozo Tsuruta, Shinichiro Yoshioka, Minako Sako, Hiromichi Shimizu, Mariko Kobayashi, Toshiyuki Sakurai, Kei Nomura, Tomoyoshi Shibuya, Masahiro Takahara, Sakiko Hiraoka, Kyohei Sugai, Shu
Alimentary Pharmacology & Therapeutics.2024; 59(11): 1413. CrossRef
Real-World Data on the Effectiveness and Safety of Filgotinib for Ulcerative Colitis in Japanese Patients: A Single-Center Experience
Takahito Toba, Ryo Karashima, Kodai Fujii, Keiichi Inoue, Nanako Inoue, Yurie Ogawa, Aya Hojo, Ai Fujimoto, Takahisa Matsuda
Cureus.2024;[Epub] CrossRef
Safety and effectiveness of tofacitinib in Korean adult patients with ulcerative colitis: post-marketing surveillance study
Hyuk Yoon, Byong Duk Ye, Sang-Bum Kang, Kang-Moon Lee, Chang Hwan Choi, Joo-young Jo, Juwon Woo, Jae Hee Cheon
BMC Gastroenterology.2024;[Epub] CrossRef
Patients’ Preference on Advanced Therapy and Follow-Up Procedure for Inflammatory Bowel Disease in Japan: A Web-Based 3A Survey
Toshifumi Morishita, Shunichi Yanai, Yosuke Toya, Takayuki Matsumoto
Inflammatory Intestinal Diseases.2024; 9(1): 174. CrossRef
The role and prospect of tofacitinib in patients with ulcerative colitis
Jun Lee
Intestinal Research.2023; 21(1): 168. CrossRef
Advances in pharmacotherapy for ulcerative colitis: a focus on JAK1 inhibitors
Alexander Goetsch, Ferdinando D’Amico, Mariangela Allocca, Gionata Fiorino, Federica Furfaro, Alessandra Zilli, Tommaso Lorenzo Parigi, Simona Radice, Laurent Peyrin-Biroulet, Silvio Danese
Expert Opinion on Pharmacotherapy.2023; 24(7): 849. CrossRef
Understanding the efficacy of individual Janus kinase inhibitors in the treatment of ulcerative colitis for future positioning in inflammatory bowel disease treatment
Hiroshi Nakase
Immunological Medicine.2023; 46(3): 121. CrossRef
Inflammation-Driven Colorectal Cancer Associated with Colitis: From Pathogenesis to Changing Therapy
Olga Maria Nardone, Irene Zammarchi, Giovanni Santacroce, Subrata Ghosh, Marietta Iacucci
Cancers.2023; 15(8): 2389. CrossRef
Extraintestinal Cancers in Inflammatory Bowel Disease: A Literature Review
Alessandro Massano, Luisa Bertin, Fabiana Zingone, Andrea Buda, Pierfrancesco Visaggi, Lorenzo Bertani, Nicola de Bortoli, Matteo Fassan, Marco Scarpa, Cesare Ruffolo, Imerio Angriman, Cristina Bezzio, Valentina Casini, Davide Giuseppe Ribaldone, Edoardo
Cancers.2023; 15(15): 3824. CrossRef
Integrated safety analysis of filgotinib for ulcerative colitis: Results from SELECTION and SELECTIONLTE
Stefan Schreiber, Gerhard Rogler, Mamoru Watanabe, Séverine Vermeire, Christian Maaser, Silvio Danese, Margaux Faes, Paul Van Hoek, Jeremy Hsieh, Ulrik Moerch, Yan Zhou, Angela de Haas, Christine Rudolph, Alessandra Oortwijn, Edward V. Loftus
Alimentary Pharmacology & Therapeutics.2023; 58(9): 874. CrossRef
Recent advances in anti-inflammatory active components and action mechanisms of natural medicines
Zhimin Wu, Tao Zhang, Xiaofei Ma, Shuai Guo, Qingqing Zhou, Arshad Zahoor, Ganzhen Deng
Inflammopharmacology.2023; 31(6): 2901. CrossRef
Filgotinib for moderately to severely active ulcerative colitis
Alessandro Mannucci, Ferdinando D’Amico, Ahmad El Saadi, Laurent Peyrin-Biroulet, Silvio Danese
Expert Review of Gastroenterology & Hepatology.2022; 16(10): 927. CrossRef

6,764 View
796 Download
12 Web of Science
12 Crossref

Inflammatory Bowel Diseases

Long-term safety and effectiveness of adalimumab in Japanese patients with Crohn’s disease: 3-year results from a real-world study: Tadakazu Hisamatsu, Yasuo Suzuki, Mariko Kobayashi, Takashi Hagiwara, Takeshi Kawaberi, Haruhiko Ogata, Toshiyuki Matsui, Mamoru Watanabe, Toshifumi Hibi; Intest Res 2021;19(4):408-418. Published online November 20, 2020; DOI: https://doi.org/10.5217/ir.2020.00025

Abstract PDF PubReader ePub

Background/Aims
Crohn’s disease is a chronic disorder; therefore, it is essential to investigate long-term safety and efficacy of treatments. This study assessed the safety and effectiveness of adalimumab for up to 3 years in Japanese patients with Crohn’s disease in real-world settings.
Methods
This was a multicenter, single-cohort, observational study of patients with Crohn’s disease. Safety assessments included incidence of adverse drug reactions. Effectiveness assessments included clinical remission, mucosal healing, and Work Productivity and Activity Impairment (WPAI).
Results
The safety and effectiveness analysis populations comprised 389 and 310 patients, respectively. Mean (standard deviation) exposure to adalimumab in the safety analysis population was 793.4 (402.8) days, with a 58.1% retention rate. A total of 105 patients (27.0%) and 43 patients (11.1%) experienced adverse drug reactions and serious adverse drug reactions, respectively, with no patient reporting tuberculosis or hepatitis B. Infections and serious infections were reported in 37 patients (9.5%) and 17 patients (4.4%), respectively. Malignancy was reported as an adverse drug reaction in 2 patients (0.5%). Remission rate increased from 37.8% (98/259) at baseline to 73.9% (167/226) at week 4 and remained > 70% over 3 years. Proportion of patients without mucosal ulcerations increased from 2.7% (2/73) at baseline to 42.3% (11/26) between years > 2 to ≤ 3. WPAI improvement started at 4 weeks, with the overall work impairment score improving from 42.7 (n = 102) at baseline to 26.9 (n = 84) at 4 weeks.
Conclusions
Results from this study confirm the long-term safety and effectiveness of adalimumab treatment in Japanese patients with Crohn’s disease in the real-world setting.

Citations

Citations to this article as recorded by

Effect of Perianal Fistula on the Quality of Life and Work Productivity of Patients with Crohn's Disease: Report of a Questionnaire Survey
Naoto Saigusa, Takeshi Inaba
Nippon Daicho Komonbyo Gakkai Zasshi.2024; 77(2): 89. CrossRef
Real-world effectiveness and safety of adalimumab in Korean patients with intestinal Behcet’s disease: a Korean Association for the Study of Intestinal Diseases (KASID) multicenter study
Seung Bum Lee, Hee Seung Hong, Chang Kyun Lee, Bo-In Lee, Sol Kim, Seong-Joon Koh, Hosun Yu, Jung-Bin Park, Sung Wook Hwang, Byong Duk Ye, Suk-Kyun Yang, Sang Hyoung Park
The Korean Journal of Internal Medicine.2023; 38(5): 661. CrossRef
Clinical features of enteric and colo-duodenal fistula in patients with Crohn’s disease
Jun Su Lee, Sang-Bum Kang, Kwangbeom Park, Yong Sik Yoon, Chang Sik Yu, Sung Wook Hwang, Byong Duk Ye, Suk-Kyun Yang, Jong Lyul Lee, Sang Hyoung Park
Intestinal Research.2023; 21(3): 406. CrossRef
TNF-Alpha Inhibitors and Ustekinumab for the Treatment of Psoriasis: Therapeutic Utility in the Era of IL-17 and IL-23 Inhibitors
Julie J. Hong, Edward K. Hadeler, Megan L. Mosca, Nicholas D. Brownstone, Tina Bhutani, Wilson J. Liao
Journal of Psoriasis and Psoriatic Arthritis.2022; 7(2): 79. CrossRef
Infliximab versus Adalimumab: Can We Choose the Right One for the Right Patients with Ulcerative Colitis?
Sang Hyoung Park, Byong Duk Ye, Suk-Kyun Yang
Gut and Liver.2022; 16(1): 138. CrossRef
Biological Therapies for the Management of Enteric Disease: Considerations for the Clinician
Adam Saleh, Usman Ansari, Shaadi Abughazaleh, Kerri Glassner, Bincy P Abraham
Biologics: Targets and Therapy.2022; Volume 16: 67. CrossRef
Prevention of postoperative recurrence in Crohn’s disease: the never-ending story
Jung-Bin Park, Sang Hyoung Park
Intestinal Research.2022; 20(3): 279. CrossRef
Updates on conventional therapies for inflammatory bowel diseases: 5-aminosalicylates, corticosteroids, immunomodulators, and anti-TNF-α
Jihye Park, Jae Hee Cheon
The Korean Journal of Internal Medicine.2022; 37(5): 895. CrossRef
Viral Hepatitis in Patients with Inflammatory Bowel Disease
Seung Hwan Shin, Sang Hyoung Park
The Korean Journal of Gastroenterology.2022; 80(2): 51. CrossRef
Adalimumab for induction of remission in patients with Crohn's disease: a systematic review and meta-analysis
Juntao Yin, Yang Li, Yangyang Chen, Chaoyang Wang, Xiaoyong Song
European Journal of Medical Research.2022;[Epub] CrossRef
Natural history of inflammatory bowel disease: a comparison between the East and the West
Eun Mi Song, Suk-Kyun Yang
Intestinal Research.2022; 20(4): 418. CrossRef
Can Anti-Tumor Necrosis Factor Agents Be Discontinued in Patients with Inflammatory Bowel Disease?
Jihye Park, Jae Hee Cheon
Gut and Liver.2021; 15(5): 641. CrossRef
Pharmacogenetics-based personalized treatment in patients with inflammatory bowel disease: A review
Ji Young Chang, Jae Hee Cheon
Precision and Future Medicine.2021; 5(4): 151. CrossRef

5,961 View
325 Download
17 Web of Science
13 Crossref

Inflammatory Bowel Diseases

Safety and effectiveness of adalimumab in the treatment of ulcerative colitis: results from a large-scale, prospective, multicenter, observational study: Haruhiko Ogata, Takashi Hagiwara, Takeshi Kawaberi, Mariko Kobayashi, Toshifumi Hibi; Intest Res 2021;19(4):419-429. Published online November 10, 2020; DOI: https://doi.org/10.5217/ir.2020.00033

Abstract PDF PubReader ePub

Background/Aims
Adalimumab has been shown to induce and maintain clinical remission in patients with moderate to severe ulcerative colitis (UC). However, no large-scale population-based studies have been performed in Japan. This study was conducted to evaluate the safety and effectiveness of adalimumab in clinical practice in Japanese patients with UC.
Methods
In this 52-week, prospective, multicenter, single-cohort, noninterventional, observational, postmarketing surveillance study, patients with moderate to severe UC received an initial subcutaneous injection of adalimumab 160 mg, followed by 80 mg at 2 weeks, and then 40 mg every other week. Safety assessments were the incidence of adverse drug reactions (ADRs) and serious ADRs. Effectiveness assessments were clinical remission, corticosteroid-free remission, mucosal healing, and change in C-reactive protein (CRP) levels from baseline.
Results
Of 1,593 registered patients, 1,523 (male, 57.6%; mean age, 41.8 years) and 1,241 patients were included in the safety and effectiveness populations, respectively. ADRs were reported in 18.1% and serious ADRs in 4.9% of patients. Clinical remission was achieved in 49.7% of patients at week 4, increasing to 74.4% at week 52. Corticosteroid-free remission rates increased over time, from 10.4% at week 4 to 53.1% at week 52. More than 60% of patients demonstrated mucosal healing at weeks 24 and 52. Mean CRP levels (mg/dL) decreased from 1.2 at baseline to 0.6 at week 4 and 0.3 at week 52.
Conclusions
This large real-world study confirmed the safety and effectiveness of adalimumab in patients with UC in Japan. No new safety concerns were identified.

Citations

Citations to this article as recorded by

Real-world effectiveness and safety of advanced therapies for the treatment of moderate-to-severe ulcerative colitis: Evidence from a systematic literature review
Peter M. Irving, Peter Hur, Raju Gautam, Xiang Guo, Severine Vermeire
Journal of Managed Care & Specialty Pharmacy.2024; 30(9): 1026. CrossRef
Real‐world experience of adalimumab therapy for patients with ulcerative colitis: A single tertiary medical center experience in Central Taiwan
Hsu‐Heng Yen, Yu‐Chun Hsu, Chu‐Hsuan Kuo, Tsui‐Chun Hsu, Yang‐Yuan Chen
Advances in Digestive Medicine.2023; 10(1): 28. CrossRef
Reviewing not Homer’s Iliad, but “Kai Bao Ben Cao”: indigo dye—the past, present, and future
Yusuke Yoshimatsu, Tomohisa Sujino, Takanori Kanai
Intestinal Research.2023; 21(2): 174. CrossRef
Safety of Adalimumab: An Analysis of the FDA Adverse Event Reporting System (FAERS) Database
Buthainah Ghanem
Jordan Journal of Pharmaceutical Sciences.2023; 16(3): 517. CrossRef
Infliximab versus Adalimumab: Can We Choose the Right One for the Right Patients with Ulcerative Colitis?
Sang Hyoung Park, Byong Duk Ye, Suk-Kyun Yang
Gut and Liver.2022; 16(1): 138. CrossRef
Adalimumab Efficacy for Management of Inflammatory Bowel Disease in Southwest Region of Iran
Pezhman Alavinejad, Sana Delavari, Abazar Parsi, Ali Akbar Shayesteh
Modern Care Journal.2022;[Epub] CrossRef
Clinical outcomes and predictors of response for adalimumab in patients with moderately to severely active ulcerative colitis: a KASID prospective multicenter cohort study
Seung Yong Shin, Soo Jung Park, Young Kim, Jong Pil Im, Hyo Jong Kim, Kang-Moon Lee, Ji Won Kim, Sung-Ae Jung, Jun Lee, Sang-Bum Kang, Sung Jae Shin, Eun Sun Kim, You Sun Kim, Tae Oh Kim, Hyun-Soo Kim, Dong Il Park, Hyung Kil Kim, Eun Soo Kim, Young-Ho Ki
Intestinal Research.2022; 20(3): 350. CrossRef
Updates on conventional therapies for inflammatory bowel diseases: 5-aminosalicylates, corticosteroids, immunomodulators, and anti-TNF-α
Jihye Park, Jae Hee Cheon
The Korean Journal of Internal Medicine.2022; 37(5): 895. CrossRef
Viral Hepatitis in Patients with Inflammatory Bowel Disease
Seung Hwan Shin, Sang Hyoung Park
The Korean Journal of Gastroenterology.2022; 80(2): 51. CrossRef
Do We Have an Opportunity to Avoid Opportunistic Infections in Asian Patients with Inflammatory Bowel Disease?
Suhyun Park, Sang Hyoung Park
Gut and Liver.2022; 16(5): 663. CrossRef
Latent and Active Tuberculosis Infection in Patients with Inflammatory Bowel Disease
Byung Chul Jin, Hee Jin Moon, Sang Wook Kim
The Korean Journal of Gastroenterology.2022; 80(2): 72. CrossRef
Effectiveness and Safety of Golimumab in Patients with Ulcerative Colitis: A Multicenter, Prospective, Postmarketing Surveillance Study
Jongwook Yu, Soo Jung Park, Hyung Wook Kim, Yun Jeong Lim, Jihye Park, Jae Myung Cha, Byong Duk Ye, Tae Oh Kim, Hyun-Soo Kim, Hyun Seok Lee, Su Young Jung, Youngdoe Kim, Chang Hwan Choi
Gut and Liver.2022; 16(5): 764. CrossRef
Circulating Profile of ECM-Related Proteins as Diagnostic Markers in Inflammatory Bowel Diseases
Katarzyna Komosinska-Vassev, Aleksandra Kałużna, Agnieszka Jura-Półtorak, Alicja Derkacz, Krystyna Olczyk
Journal of Clinical Medicine.2022; 11(19): 5618. CrossRef
Can Anti-Tumor Necrosis Factor Agents Be Discontinued in Patients with Inflammatory Bowel Disease?
Jihye Park, Jae Hee Cheon
Gut and Liver.2021; 15(5): 641. CrossRef

6,199 View
343 Download
12 Web of Science
14 Crossref

Inflammatory bowel diseases

Phenotypic characteristics of pediatric inflammatory bowel disease in Japan: results from a multicenter registry: Katsuhiro Arai, Reiko Kunisaki, Fumihiko Kakuta, Shin-ichiro Hagiwara, Takatsugu Murakoshi, Tadahiro Yanagi, Toshiaki Shimizu, Sawako Kato, Takashi Ishige, Tomoki Aomatsu, Mikihiro Inoue, Takeshi Saito, Itaru Iwama, Hisashi Kawashima, Hideki Kumagai, Hitoshi Tajiri, Naomi Iwata, Takahiro Mochizuki, Atsuko Noguchi, Toshihiko Kashiwabara, Hirotaka Shimizu, Yasuo Suzuki, Yuri Hirano, Takeo Fujiwara; Intest Res 2020;18(4):412-420. Published online August 18, 2020; DOI: https://doi.org/10.5217/ir.2019.00130

Abstract PDF PubReader ePub

Background/Aims
There are few published registry studies from Asia on pediatric inflammatory bowel disease (IBD). Registry network data enable comparisons among ethnic groups. This study examined the characteristics of IBD in Japanese children and compared them with those in European children.
Methods
This was a cross-sectional multicenter registry study of newly diagnosed Japanese pediatric IBD patients. The Paris classification was used to categorize IBD features, and results were compared with published EUROKIDS data.
Results
A total of 265 pediatric IBD patients were initially registered, with 22 later excluded for having incomplete demographic data. For the analysis, 91 Crohn’s disease (CD), 146 ulcerative colitis (UC), and 6 IBD-unclassified cases were eligible. For age at diagnosis, 20.9% of CD, 21.9% of UC, and 83.3% of IBD-unclassified cases were diagnosed before age 10 years. For CD location, 18.7%, 13.2%, 64.8%, 47.3%, and 20.9% were classified as involving L1 (ileocecum), L2 (colon), L3 (ileocolon), L4a (esophagus/stomach/duodenum), and L4b (jejunum/proximal ileum), respectively. For UC extent, 76% were classified as E4 (pancolitis). For CD behavior, B1 (non-stricturing/non-penetrating), B2 (stricturing), B3 (penetrating), and B2B3 were seen in 83.5%, 11.0%, 3.3%, and 2.2%, respectively. A comparison between Japanese and European children showed less L2 involvement (13.2% vs. 27.3%, P< 0.01) but more L4a (47.3% vs. 29.6%, P< 0.01) and L3 (64.8% vs. 52.7%, P< 0.05) involvement in Japanese CD children. Pediatric perianal CD was more prevalent in Japanese children (34.1% vs. 9.7%, P< 0.01).
Conclusions
Upper gastrointestinal and perianal CD lesions are more common in Japanese children than in European children.

Citations

Citations to this article as recorded by

Prognosis of pediatric ulcerative colitis after infliximab failure: A multicenter registry‐based cohort study
Ryusuke Nambu, Takahiro Kudo, Nao Tachibana, Hirotaka Shimizu, Tatsuki Mizuochi, Sawako Kato, Mikihiro Inoue, Hideki Kumagai, Takashi Ishige, Reiko Kunisaki, Atsuko Noguchi, Toshifumi Yodoshi, Shin‐Ichiro Hagiwara, Shigeo Nishimata, Fumihiko Kakuta, Takes
Journal of Gastroenterology and Hepatology.2024; 39(2): 312. CrossRef
Prevalence of Inflammatory Bowel Disease Unclassified, as Estimated Using the Revised Porto Criteria, among Korean Pediatric Patients with Inflammatory Bowel Disease
Sung Hee Lee, Minsoo Shin, Seo Hee Kim, Seong Pyo Kim, Hyung-Jin Yoon, Yangsoon Park, Jaemoon Koh, Seak Hee Oh, Jae Sung Ko, Jin Soo Moon, Kyung Mo Kim
Pediatric Gastroenterology, Hepatology & Nutrition.2024; 27(4): 206. CrossRef
Clinical Efficacy and Future Application of Indigo Naturalis in the Treatment of Ulcerative colitis
Dianzhen Wu, Qi Huang, Yingbi Xu, Ruiyi Cao, Ming Yang, Jin Xie, Dingkun Zhang
Journal of Ethnopharmacology.2024; : 118782. CrossRef
Comparison of Clinical Outcomes in Pediatric Patients with Ileocolonic Crohn Disease Treated with Infliximab Versus Adalimumab
Eliana Fanous, Tal Marshanski, Noa Tal, Manar Matar, Yael Weintraub, Raanan Shamir, Dror S. Shouval
Journal of Pediatric Gastroenterology & Nutrition.2023; 77(3): 358. CrossRef
Caracterización clínica y terapéutica de una cohorte multicéntrica de pacientes con enfermedad inflamatoria intestinal en Colombia
Viviana Parra-Izquierdo, Cristian Flórez Sarmiento, Juan Sebastián Frías-Ordoñez, Melquicedec Vargas, Joshua Kock, Natalia Lozano Escobar, Juan Ricardo Márquez
Gastroenterología y Hepatología.2023; 46(8): 585. CrossRef
Potential of Gut Microbe-Derived Extracellular Vesicles to Differentiate Inflammatory Bowel Disease Patients from Healthy Controls
Min Heo, Young Soo Park, Hyuk Yoon, Nam-Eun Kim, Kangjin Kim, Cheol Min Shin, Nayoung Kim, Dong Ho Lee
Gut and Liver.2023; 17(1): 108. CrossRef
Medical management of pediatric inflammatory bowel disease in the Asia‐Pacific region: A position paper by the Asian Pan‐Pacific Society for Pediatric Gastroenterology, Hepatology, and Nutrition (APPSPGHAN) PIBD Working Group
Way Seah Lee, Katsuhiro Arai, George Alex, Suporn Treepongkaruna, Kyung Mo Kim, Chee Liang Choong, Karen S. C. Mercado, Andy Darma, Anshu Srivastava, Marion M. Aw
Journal of Gastroenterology and Hepatology.2023; 38(4): 523. CrossRef
Clinical outcome of ulcerative colitis with severe onset in children: a multicenter prospective cohort study
Ryusuke Nambu, Katsuhiro Arai, Takahiro Kudo, Takatsugu Murakoshi, Reiko Kunisaki, Tatsuki Mizuochi, Sawako Kato, Hideki Kumagai, Mikihiro Inoue, Takashi Ishige, Takeshi Saito, Atsuko Noguchi, Toshifumi Yodoshi, Shin-Ichiro Hagiwara, Naomi Iwata, Shigeo N
Journal of Gastroenterology.2023; 58(5): 472. CrossRef
Mucosal immune systems of pediatric inflammatory bowel disease: A review
Takahiro Kudo, Toshiaki Shimizu
Pediatrics International.2023;[Epub] CrossRef
Clinical and therapeutic characterisation of a multicentre cohort of patients with inflammatory bowel disease in Colombia
Viviana Parra-Izquierdo, Cristian Flórez Sarmiento, Juan Sebastián Frías-Ordoñez, Melquicedec Vargas, Joshua Kock, Natalia Lozano Escobar, Juan Ricardo Márquez
Gastroenterología y Hepatología (English Edition).2023; 46(8): 585. CrossRef
Clinical characteristics and nursing diagnoses of pediatric patients hospitalized with inflammatory bowel disease: a single-center retrospective study in South Korea
Sung-Yoon Jo, Kyung-Sook Bang
Child Health Nursing Research.2023; 29(3): 218. CrossRef
Clinical Features and Long-Term Outcomes of Paediatric-Onset Inflammatory Bowel Disease in a Population-Based Cohort in the Songpa-Kangdong District of Seoul, Korea
Sang Hyoung Park, Jong Pil Im, Hyunju Park, Seung Kyu Jeong, Ji Hyun Lee, Kyoung Hoon Rhee, Young-Ho Kim, Sung Noh Hong, Kyung Ho Kim, Seung In Seo, Jae Myung Cha, Sun Yong Park, Joo Sung Kim, Hyuk Yoon, Sung Hoon Kim, Jisun Jang, Jeong Hwan Kim, Seong O
Journal of Crohn's and Colitis.2022; 16(2): 207. CrossRef
Long-term Disease Course of Crohn’s Disease: Changes in Disease Location, Phenotype, Activities, and Predictive Factors
Choong Wui Cho, Myung-Won You, Chi Hyuk Oh, Chang Kyun Lee, Sung Kyoung Moon
Gut and Liver.2022; 16(2): 157. CrossRef
Symptom Improvement of ulceRative colitis after an Induction dose of UStekinumab in Japanese clinical practice (SIRIUS), measured using patient-reported outcomes: a prospective observational study
Katsuyoshi Matsuoka, Katsumasa Nagano, Shinya Nagasaki, Yoko Murata, Tadakazu Hisamatsu
BMJ Open.2022; 12(5): e060081. CrossRef
Personalized medicine in inflammatory bowel disease: Perspectives on Asia
Su Hyun Park, Sang Hyoung Park
Journal of Gastroenterology and Hepatology.2022; 37(8): 1434. CrossRef
Phenotypic Pattern of Early Versus Later-Onset Pediatric Inflammatory Bowel Disease in a Eurasian Country
Bilge S. Akkelle, Deniz Ertem, Burcu Volkan, Engin Tutar
Journal of Pediatric Gastroenterology & Nutrition.2022; 75(4): e61. CrossRef
Clinical features of very early-onset inflammatory bowel disease in Japan: a retrospective single-center study
Masaaki Usami, Ichiro Takeuchi, Reiko Kyodo, Yuri Hirano, Kosuke Kashiwagi, Hiroki Fujikawa, Hirotaka Shimizu, Toshinao Kawai, Katsuhiro Arai
Intestinal Research.2022; 20(4): 475. CrossRef
SYSTEMATIC REVIEW AND META - ANALYSIS OF THE FREQUENCY AND RE-CLASSIFICATION TRENDS OF PEDIATRIC INFLAMMATORY BOWEL DISEASE - UNCLASSIFIED
Rishi BOLIA, Akhil Dhanesh GOEL
Arquivos de Gastroenterologia.2022; 59(4): 531. CrossRef
Comparison between Pediatric Crohn’s Disease and Ulcerative Colitis at Diagnosis in Korea: Results from a Multicenter, Registry-Based, Inception Cohort Study
Sowon Park, Ben Kang, Seung Kim, Sujin Choi, Hyo Rim Suh, Eun Sil Kim, Ji Hyung Park, Mi Jin Kim, Yon Ho Choe, Yeoun Joo Lee, Jae Hong Park, Eell Ryoo, Hong Koh, Byung-Ho Choe
Gut and Liver.2022; 16(6): 921. CrossRef
Epidemiology and diagnosis of inflammatory bowel diseases
Kang-Moon Lee
Journal of the Korean Medical Association.2021; 64(9): 579. CrossRef
Very early onset inflammatory bowel disease in a South Asian country where inflammatory bowel disease is emerging: a distinct clinical phenotype from later onset disease
Rupa Banerjee, Partha Pal, Zaheer Nabi, Upender Shava, Girish Ganesh, D. Nageshwar Reddy
Intestinal Research.2021; 19(4): 398. CrossRef
Incidentally Detected Asymptomatic Perianal Abscess in an Adolescent during Crohn's Disease Diagnosis: Is Routine Pelvic Imaging Required in Korean Pediatric Patients at Diagnosis?
Soo Hyun Um, Sang Woo Lee, Ki Hwan Song, So Mi Lee, Byung-Ho Choe, Yoo Min Lee, Ben Kang
Pediatric Gastroenterology, Hepatology & Nutrition.2021; 24(6): 564. CrossRef

6,107 View
202 Download
20 Web of Science
22 Crossref

Inflammatory bowel diseases

Anti-MAdCAM-1 antibody (PF-00547659) for active refractory Crohn’s disease in Japanese and Korean patients: the OPERA study: Masayuki Saruta, Dong Il Park, Young-Ho Kim, Suk-Kyun Yang, Byung-Ik Jang, Jae Hee Cheon, Jong Pil Im, Takanori Kanai, Tatsuro Katsuno, Yoh Ishiguro, Makoto Nagaoka, Naoki Isogawa, Yinhua Li, Anindita Banerjee, Alaa Ahmad, Mina Hassan-Zahraee, Robert Clare, Kenneth J. Gorelick, Fabio Cataldi, Mamoru Watanabe, Toshifumi Hibi; Intest Res 2020;18(1):45-55. Published online January 30, 2020; DOI: https://doi.org/10.5217/ir.2019.00039

Abstract PDF PubReader ePub

Background/Aims
PF-00547659 is a monoclonal antibody against human mucosal addressin cell adhesion molecule-1 (MAdCAM-1) that prevents the binding of α4β7+ lymphocytes to MAdCAM-expressing sites in the gastrointestinal tract with high affinity and selectivity, and is being developed for the treatment of Crohn’s disease (CD).
Methods
OPERA is a randomized, multicenter, double-blind, placebo-controlled study to investigate the efficacy, safety, and pharmacokinetics of PF-00547659 following subcutaneous administration in subjects with active CD, a history of failure or intolerance to anti-tumor necrosis factor and/or immunosuppressants, high-sensitivity C-reactive protein > 3.0 mg/L, and ulcers on colonoscopy. The primary endpoint was Crohn’s Disease Activity Index-70 response at week 8 or 12. Subpopulation analyses for Asian subjects were performed as some differences are observed in genetics and clinical phenotypes in Asian CD patients compared with Western patients.
Results
In this study, 265 CD subjects were randomized, with a subpopulation of 21 subjects (8 Japanese and 13 Korean) defined as the Asian population. In the overall and Asian populations; PF-00547659 was pharmacologically active as evidenced by soluble MAdCAM and circulating β7+ central memory CD4+ T-lymphocytes, although no clear evidence of efficacy was observed in any clinical endpoints; pharmacokinetics of PF-00547659 in the Asian subpopulation was generally comparable to the overall population; and the safety profile of PF-00547659 appeared acceptable up to 12 weeks of treatment.
Conclusions
In the overall and Asian populations, efficacy of PF-00547659 could not be demonstrated using any clinical endpoints compared with placebo. Pharmacokinetics and safety of PF-00547659 were generally comparable. Further studies with larger numbers of patients are required to confirm our results. (Trial Registration Number: NCT01276509)

Citations

Citations to this article as recorded by

Novel Histone Deacetylase 6 Inhibitor Confers Anti-inflammatory Effects and Enhances Gut Barrier Function
Jae-Young Lee, Hyun Woo Ma, Ji Hyung Kim, I Seul Park, Mijeong Son, Keun Ho Ryu, Jieun Shin, Seung Won Kim, Jae Hee Cheon
Gut and Liver.2023; 17(5): 766. CrossRef
Downregulation of Heat Shock Protein 72 Contributes to Fibrostenosis in Crohn’s Disease
Seung Won Kim, Jae-Young Lee, Han Cheol Lee, Jae Bum Ahn, Ji Hyung Kim, I Seul Park, Jae Hee Cheon, Duk Hwan Kim
Gut and Liver.2023; 17(6): 905. CrossRef
Targeting Immune Cell Trafficking – Insights From Research Models and Implications for Future IBD Therapy
Maximilian Wiendl, Emily Becker, Tanja M. Müller, Caroline J. Voskens, Markus F. Neurath, Sebastian Zundler
Frontiers in Immunology.2021;[Epub] CrossRef
Renin–angiotensin system in intestinal inflammation—Angiotensin inhibitors to treat inflammatory bowel diseases?
Hanne Salmenkari, Riitta Korpela, Heikki Vapaatalo
Basic & Clinical Pharmacology & Toxicology.2021; 129(3): 161. CrossRef
Anti-integrin drugs in clinical trials for inflammatory bowel disease (IBD): insights into promising agents
Virginia Solitano, Tommaso Lorenzo Parigi, Elisa Ragaini, Silvio Danese
Expert Opinion on Investigational Drugs.2021; 30(10): 1037. CrossRef
Emerging therapeutic options in inflammatory bowel disease
Jesus K Yamamoto-Furusho, Norma N Parra-Holguín
World Journal of Gastroenterology.2021; 27(48): 8242. CrossRef

15,547 View
188 Download
7 Web of Science
6 Crossref

Inflammatory bowel diseases

Efficacy and safety of abrilumab, an α4β7 integrin inhibitor, in Japanese patients with moderate-to-severe ulcerative colitis: a phase II study: Toshifumi Hibi, Satoshi Motoya, Toshifumi Ashida, Souken Sai, Yukinori Sameshima, Shiro Nakamura, Atsuo Maemoto, Masahiro Nii, Barbara A Sullivan, Robert A. Gasser Jr, Yasuo Suzuki; Intest Res 2019;17(3):375-386. Published online February 12, 2019; DOI: https://doi.org/10.5217/ir.2018.00141

Abstract PDF PubReader ePub

Background/Aims
Inhibition of α4β7 integrin has been shown to be effective for induction and maintenance therapy in patients with ulcerative colitis (UC). We investigated the effects of varying doses of the α4β7 inhibitor abrilumab in Japanese patients with moderate-to-severe UC despite conventional treatments.
Methods
In this randomized, double-blind, placebocontrolled study, 45 UC patients were randomized to abrilumab 21 mg (n=11), 70 mg (n=12), 210 mg (n=9), or placebo (n=13) via subcutaneous (SC) injection for 12 weeks. The double-blind period was followed by a 36-week open-label period, in which all patients received abrilumab 210 mg SC every 12 weeks, and a 28-week safety follow-up period. The primary efficacy variable was clinical remission at week 8 (total Mayo score ≤2 points with no individual subscore >1 point).
Results
Clinical remission at week 8 was 4 out of 31 (12.9%) overall in the abrilumab groups versus 0 out of 13 in the placebo group (abrilumab 21 mg, 1/10 [10.0%]; 70 mg, 2/12 [16.7%]; 210 mg, 1/9 [11.1%]). In both the double-blind and open-label periods, fewer patients in the abrilumab groups experienced ≥1 adverse event compared with those in the placebo group. There were no cases of progressive multifocal leukoencephalopathy and no deaths.
Conclusions
Abrilumab 70 mg and 210 mg yielded numerically better results in terms of clinical remission rate at Week 8 than placebo, with the 210 mg dose showing more consistent treatment effects. Abrilumab was well tolerated in Japanese patients with UC.

Citations

Citations to this article as recorded by

Drug-Induced Progressive Multifocal Leukoencephalopathy (PML): A Systematic Review and Meta-Analysis
Lorenzo Vittorio Rindi, Drieda Zaçe, Neva Braccialarghe, Barbara Massa, Virginia Barchi, Roberta Iannazzo, Ilenia Fato, Francesco De Maria, Dimitra Kontogiannis, Vincenzo Malagnino, Loredana Sarmati, Marco Iannetta
Drug Safety.2024; 47(4): 333. CrossRef
Targeting integrin pathways: mechanisms and advances in therapy
Xiaocong Pang, Xu He, Zhiwei Qiu, Hanxu Zhang, Ran Xie, Zhiyan Liu, Yanlun Gu, Nan Zhao, Qian Xiang, Yimin Cui
Signal Transduction and Targeted Therapy.2023;[Epub] CrossRef
Emerging drugs for the treatment of moderately to severely active ulcerative colitis: review of phase II and III clinical trials
Laura Neurath, Ferdinando D’Amico, Silvio Danese
Expert Opinion on Emerging Drugs.2023; 28(1): 27. CrossRef
Inflammatory Bowel Disease: Emerging Therapies and Future Treatment Strategies
Elisabetta Bretto, Davide Giuseppe Ribaldone, Gian Paolo Caviglia, Giorgio Maria Saracco, Elisabetta Bugianesi, Simone Frara
Biomedicines.2023; 11(8): 2249. CrossRef
Integrin signaling in cancer: bidirectional mechanisms and therapeutic opportunities
Siyi Li, Chibuzo Sampson, Changhao Liu, Hai-long Piao, Hong-Xu Liu
Cell Communication and Signaling.2023;[Epub] CrossRef
Immunology of Inflammatory Bowel Disease: Molecular Mechanisms and Therapeutics
Quan Lu, Mei-feng Yang, Yu-jie Liang, Jing Xu, Hao-ming Xu, Yu-qiang Nie, Li-sheng Wang, Jun Yao, De-feng Li
Journal of Inflammation Research.2022; Volume 15: 1825. CrossRef
Factors predicting clinical and endoscopic remission with placebo therapy in East Asian patients with ulcerative colitis: a systematic review and meta-analysis
Jian Zeng, Zhong Wang, Xiao-Jun Yang
European Journal of Clinical Pharmacology.2022; 78(7): 1069. CrossRef
Tackling Inflammatory Bowel Diseases: Targeting Proinflammatory Cytokines and Lymphocyte Homing
Yijie Song, Man Yuan, Yu Xu, Hongxi Xu
Pharmaceuticals.2022; 15(9): 1080. CrossRef
Targeting Immune Cell Trafficking – Insights From Research Models and Implications for Future IBD Therapy
Maximilian Wiendl, Emily Becker, Tanja M. Müller, Caroline J. Voskens, Markus F. Neurath, Sebastian Zundler
Frontiers in Immunology.2021;[Epub] CrossRef
Anti-Integrins for the Treatment of Inflammatory Bowel Disease: Current Evidence and Perspectives
John Gubatan, Kian Keyashian, Samuel JS Rubin, Jenny Wang, Cyrus Buckman, Sidhartha Sinha
Clinical and Experimental Gastroenterology.2021; Volume 14: 333. CrossRef
Anti-integrin drugs in clinical trials for inflammatory bowel disease (IBD): insights into promising agents
Virginia Solitano, Tommaso Lorenzo Parigi, Elisa Ragaini, Silvio Danese
Expert Opinion on Investigational Drugs.2021; 30(10): 1037. CrossRef
Efficacy and safety of a new vedolizumab subcutaneous formulation in Japanese patients with moderately to severely active ulcerative colitis
Taku Kobayashi, Hiroaki Ito, Toshifumi Ashida, Tadashi Yokoyama, Masakazu Nagahori, Tomoki Inaba, Mitsuhiro Shikamura, Takayoshi Yamaguchi, Tetsuharu Hori, Philippe Pinton, Mamoru Watanabe, Toshifumi Hibi
Intestinal Research.2021; 19(4): 448. CrossRef
Emerging therapeutic options in inflammatory bowel disease
Jesus K Yamamoto-Furusho, Norma N Parra-Holguín
World Journal of Gastroenterology.2021; 27(48): 8242. CrossRef
Subcutaneous integrin inhibitors may provide more treatment options for patients with moderate-to-severe ulcerative colitis
Hyuk Yoon
Intestinal Research.2019; 17(3): 283. CrossRef

7,218 View
197 Download
15 Web of Science
14 Crossref

Efficacy and safety of ustekinumab in Japanese patients with moderately to severely active Crohn's disease: a subpopulation analysis of phase 3 induction and maintenance studies: Toshifumi Hibi, Yuya Imai, Yoko Murata, Nobuko Matsushima, Richuan Zheng, Christopher Gasink; Intest Res 2017;15(4):475-486. Published online October 23, 2017; DOI: https://doi.org/10.5217/ir.2017.15.4.475

Abstract PDF Supplementary Material PubReader ePub

<b>Background/Aims</b><br/>

Efficacy and safety of ustekinumab were evaluated in a Japanese subpopulation with moderately to severely active Crohn's disease (CD) in UNITI-1, UNITI-2 and IM-UNITI studies and results were compared with the overall population.

Methods

Overall, patients in UNITI-1 (Japan, n=56; failed response to tumor necrosis factor antagonist) and UNITI-2 (Japan, n=26; failed response to prior conventional therapy) were randomized to placebo or ustekinumab intravenous induction (130 mg or ~6 mg/kg) at week 0. Responders to ustekinumab induction therapy (Japan, n=21) were randomized to placebo or ustekinumab (90 mg, subcutaneous) maintenance (every 12 weeks [q12w] or 8 weeks [q8w]) in IM-UNITI. The primary endpoint was clinical response at week 6 for induction studies and clinical remission at week 44 for maintenance study.

Results

Percentage of patients achieving clinical response at week 6 was greater in ustekinumab 130 mg and ~6 mg/kg groups than in the placebo group (UNITI-1: 36.8% and 31.6% vs. 27.8%, respectively, for Japanese; 34.3% and 33.7% vs. 21.5%, respectively, for overall; UNITI-2: 37.5% and 55.6% vs. 11.1%, respectively, for Japanese; 51.7% and 55.5% vs. 28.7%, respectively, for overall). Clinical remission rate at week 44 during maintenance was greater in the ustekinumab 90 mg SC q12w and q8w groups than in the placebo group (50.0% and 55.6% vs. 25.0%, respectively, for Japanese; 48.8% and 53.1% vs. 35.9%, respectively, for overall). Efficacy and safety results observed in the Japanese subpopulation were generally consistent with those in the overall population.

Conclusions

Ustekinumab could be considered as a new therapeutic option for moderately to severely active CD in Japanese patients. Both ustekinumab induction and maintenance treatments were generally well tolerated (Clinical Trial Registration: NCT01369329, NCT01369342, NCT01369355).

Citations

Citations to this article as recorded by

Saudi consensus guidance for the diagnosis and management of inflammatory bowel disease in children and adolescents
Omar I. Saadah, Turki AlAmeel, Ahmed Al Sarkhy, Mohammed Hasosah, Abdulrahman Al-Hussaini, Majid A. Almadi, Badr Al-Bawardy, Talal A. Altuwaijri, Mohammed AlEdreesi, Shakir A. Bakkari, Othman R. Alharbi, Nahla A. Azzam, Abdulelah Almutairdi, Khalidah A. A
Saudi Journal of Gastroenterology.2024;[Epub] CrossRef
The treatment of inflammatory bowel disease with monoclonal antibodies in Asia
Yu Chen, Guolin Zhang, Yuewen Yang, Shuangshuang Zhang, Haozheng Jiang, Kang Tian, Arenbaoligao, Dapeng Chen
Biomedicine & Pharmacotherapy.2023; 157: 114081. CrossRef
A Retrospective Cohort Study of Clinical Features and Treatment Patterns With Ustekinumab in Patients With Crohn Disease Utilizing a Health Care Database in Japan
Yanfang Liu, Choo Hua Goh, Hong Qiu, Kuan-Chih Huang, Hsingwen Chung, Carine Saadoun
Annals of Pharmacotherapy.2023; 57(9): 1053. CrossRef
Real-world effectiveness and safety of ustekinumab induction therapy for Korean patients with Crohn’s disease: a KASID prospective multicenter study
Kyunghwan Oh, Hee Seung Hong, Nam Seok Ham, Jungbok Lee, Sang Hyoung Park, Suk-Kyun Yang, Hyuk Yoon, You Sun Kim, Chang Hwan Choi, Byong Duk Ye
Intestinal Research.2023; 21(1): 137. CrossRef
A critical review of ustekinumab for the treatment of active ulcerative colitis in adults
Sophie Vieujean, Edouard Louis, Silvio Danese, Laurent Peyrin-Biroulet
Expert Review of Gastroenterology & Hepatology.2023; 17(5): 413. CrossRef
Feasibility of a Clinical Decision Support Tool for Ustekinumab to Predict Clinical Remission and Relapse in Patients With Crohn’s Disease: A Multicenter Observational Study
Jihye Park, Jaeyoung Chun, Hyuk Yoon, Jae Hee Cheon
Inflammatory Bowel Diseases.2022;[Epub] CrossRef
Management of inflammatory bowel disease beyond tumor necrosis factor inhibitors: novel biologics and small-molecule drugs
Soo-Young Na, You Sun Kim
The Korean Journal of Internal Medicine.2022; 37(5): 906. CrossRef
Association of Anti–Tumor Necrosis Factor Therapy With Mortality Among Veterans With Inflammatory Bowel Disease
Shirley Cohen-Mekelburg, Beth I. Wallace, Tony Van, Wyndy L. Wiitala, Shail M. Govani, Jennifer Burns, Rachel Lipson, Huifeng Yun, Jason Hou, James D. Lewis, Jason A. Dominitz, Akbar K. Waljee
JAMA Network Open.2021; 4(3): e210313. CrossRef
Evidence-based clinical practice guidelines for inflammatory bowel disease 2020
Hiroshi Nakase, Motoi Uchino, Shinichiro Shinzaki, Minoru Matsuura, Katsuyoshi Matsuoka, Taku Kobayashi, Masayuki Saruta, Fumihito Hirai, Keisuke Hata, Sakiko Hiraoka, Motohiro Esaki, Ken Sugimoto, Toshimitsu Fuji, Kenji Watanabe, Shiro Nakamura, Nagamu I
Journal of Gastroenterology.2021; 56(6): 489. CrossRef
Safety and effectiveness of ustekinumab in Crohn's disease: Interim results of post‐marketing surveillance in Japan
Seiji Yokoyama, Teita Asano, Katsumasa Nagano, Hiroaki Tsuchiya, Masayuki Takagishi, Shigeharu Tsujioka, Naomi Miura, Takayuki Matsumoto
Journal of Gastroenterology and Hepatology.2021; 36(11): 3069. CrossRef
Translating Treg Therapy for Inflammatory Bowel Disease in Humanized Mice
Sushmita Negi, Sheetal Saini, Nikunj Tandel, Kiran Sahu, Ravi P.N. Mishra, Rajeev K. Tyagi
Cells.2021; 10(8): 1847. CrossRef
Efficacy and safety of ustekinumab in East Asian patients with moderately to severely active ulcerative colitis: a subpopulation analysis of global phase 3 induction and maintenance studies (UNIFI)
Tadakazu Hisamatsu, Hyo Jong Kim, Satoshi Motoya, Yasuo Suzuki, Yoshifumi Ohnishi, Noriyuki Fujii, Nobuko Matsushima, Richuan Zheng, Colleen W. Marano
Intestinal Research.2021; 19(4): 386. CrossRef
Efficacy and safety of a new vedolizumab subcutaneous formulation in Japanese patients with moderately to severely active ulcerative colitis
Taku Kobayashi, Hiroaki Ito, Toshifumi Ashida, Tadashi Yokoyama, Masakazu Nagahori, Tomoki Inaba, Mitsuhiro Shikamura, Takayoshi Yamaguchi, Tetsuharu Hori, Philippe Pinton, Mamoru Watanabe, Toshifumi Hibi
Intestinal Research.2021; 19(4): 448. CrossRef
Interleukin 23 and autoimmune diseases: current and possible future therapies
Ahmad Ismail Khaled Abdo, Gee Jun Tye
Inflammation Research.2020; 69(5): 463. CrossRef
Long-Term Clinical Effectiveness of Ustekinumab in Patients With Crohn’s Disease: A Retrospective Cohort Study
Takahiro Ito, Atsuo Maemoto, Takehiko Katsurada, Hiroki Tanaka, Satoshi Motoya, Nobuhiro Ueno, Mikihiro Fujiya, Toshifumi Ashida, Daisuke Hirayama, Hiroshi Nakase
Crohn's & Colitis 360.2020;[Epub] CrossRef
Novel drug delivery systems of Chinese medicine for the treatment of inflammatory bowel disease
Caifang Gao, Lijuan Liu, Yangyang Zhou, Zhaoxiang Bian, Shengpeng Wang, Yitao Wang
Chinese Medicine.2019;[Epub] CrossRef
Ustekinumab is effective in biological refractory Crohn’s disease patients–regardless of approval study selection criteria
Sadik Saman, Martin Goetz, Judith Wendler, Nisar P. Malek, Jan Wehkamp, Thomas Klag
Intestinal Research.2019; 17(3): 340. CrossRef
Perspectives on Current and Novel Treatments for Inflammatory Bowel Disease
Soo-Young Na, Won Moon
Gut and Liver.2019; 13(6): 604. CrossRef
Anti-IL-12/23p40 antibodies for maintenance of remission in Crohn's disease
Sarah C Davies, Tran M Nguyen, Claire E Parker, John K MacDonald, Vipul Jairath, Reena Khanna
Cochrane Database of Systematic Reviews.2019;[Epub] CrossRef
Novel treatments for inflammatory bowel disease
Hyo Sun Lee, Soo-Kyung Park, Dong Il Park
The Korean Journal of Internal Medicine.2018; 33(1): 20. CrossRef
Emerging Therapies: What Are Promising in the Near Future?
Geom Seog Seo, Sung Hee Lee
The Korean Journal of Gastroenterology.2018; 71(2): 81. CrossRef

6,439 View
141 Download
18 Web of Science
21 Crossref

First
Prev
Page of 1
Next
Last

Search